Form 483

Russell A. Foulk, MD Form 483, 2010-11-01

FDA issued a Form 483 to Russell A. Foulk, MD on 2010-11-01 with 2 public-safe observations.

483· Form 483 issued2 observations

Russell A. Foulk, MD · Pleasant Grove, United States · Issued November 1, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

1 Nov 2010
21 CFR 50.27(a)

Consent form not approved/signed/dated

Cited by Edward D Harris

1 Nov 2010
21 CFR 312.60

FD-1572, protocol compliance

Cited by Edward D Harris

Inspected site

RARussell A. Foulk, MDPleasant Grove, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 50.27(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere